Lercaril 10 mg/10 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Lercanidipine hydrochloride; Enalapril maleate

Available from:

Recordati Ireland Limited

ATC code:

C09BB; C09BB02

INN (International Name):

Lercanidipine hydrochloride; Enalapril maleate

Dosage:

10 mg/10 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

ACE inhibitors and calcium channel blockers; enalapril and lercanidipine

Authorization status:

Marketed

Authorization date:

2008-08-22

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
LERCARIL 10 MG/10 MG FILM-COATED TABLETS
ENALAPRIL MALEATE/LERCANIDIPINE HYDROCHLORIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Lercaril is and what it is used for
2.
What you need to know before you take Lercaril
3.
How to take Lercaril
4.
Possible side effects
5.
How to store Lercaril
6.
Contents of the pack and other information
1.
WHAT LERCARIL IS AND WHAT IT IS USED FOR
Lercaril is a fixed combination of an ACE-inhibitor (enalapril) and a
calcium channel blocker
(lercanidipine), two medicines that lower blood pressure.
Lercaril is used to treat high blood pressure (hypertension) in adult
patients whose blood pressure is
not adequately controlled by lercanidipine 10 mg alone. Lercaril
should not be used for initial
treatment of hypertension.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LERCARIL
DO NOT TAKE LERCARIL:
•
If you are allergic (hypersensitive) to enalapril maleate or
lercanidipine hydrochloride or to any
other ingredients of this medicine (listed in section 6).
•
If you have ever had an allergic reaction to a type of medicine
similar to those contained in
Lercaril, i.e. medicines called ACE-inhibitors or calcium channel
blockers.
•
If you have ever had swelling of your face, lips, mouth, tongue or
throat which caused difficulty in
swallowing or breathing (angioedema) after taking a type of medicine
called ACE-inhibitors, or
when the reason why was not known or it was inherited.
•
If you have taken or are currently taking sacub

Summary of Product characteristics

Health Products Regulatory Authority
16 July 2021
CRN00C30X
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lercaril 10 mg/10 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg enalapril maleate (equivalent
to 7.64 mg enalapril) and 10 mg lercanidipine
hydrochloride (equivalent to 9.44 mg lercanidipine).
Excipients with known effect:
each tablet contains 102.0 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, circular, biconvex tablets of 8.5 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension in patients whose blood pressure
is not adequately controlled by lercanidipine 10 mg
alone.
Fixed combination Lercaril 10 mg/10 mg should not be used for initial
treatment of hypertension.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Patients whose blood pressure is not adequately controlled by
lercanidipine 10 mg alone could either be titrated up to
lercanidipine 20 mg monotherapy or switched to fixed combination
Lercaril 10 mg/10 mg.
Individual dose titration with the components can be recommended. When
clinically appropriate, direct change from
monotherapy to the fixed combination may be considered.
Posology
The recommended dose is one tablet once a day at least 15 minutes
before meals.
_Elderly:_
The dose should depend on the patient's renal function (see "Use in
renal impairment").
_Renal impairment:_
Lercaril is contraindicated in patients with severe renal dysfunction
(creatinine clearance <30 ml/min) or in patients undergoing
haemodialysis (see section 4.3 and 4.4). Particular caution is needed
when initiating treatment in patients with mild to
moderate renal dysfunction.
_Hepatic impairment:_
Lercaril is contraindicated in severe hepatic dysfunction. Particular
caution is needed when initiating treatment in patients with
mild to moderate hepatic dysfunction.
_ _
_Paediatric population:_
There is no relevant use of Lercaril